Cleared Traditional

K801332 - AMPCO SKIN SCRUB TRAYS

K801332 is an FDA 510(k) clearance for AMPCO SKIN SCRUB TRAYS, manufactured by Associated Medical Products Co.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801332 · Associated Medical Products Co. · General Hospital
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Jun 1980
Decision
17d
Days
Class 2
Risk

K801332 is an FDA 510(k) clearance for the AMPCO SKIN SCRUB TRAYS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Associated Medical Products Co. (Walker, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Associated Medical Products Co. devices

FDA 510(k) Submission Details - K801332

510(k) Number K801332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date June 20, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 122
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K801332.
HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY
K802577 · Associated Medical Products Co. · Nov 1980
AMPCO DRESSING CHANGE TRAYS
K801333 · Associated Medical Products Co. · Aug 1980
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
K801331 · Associated Medical Products Co. · Aug 1980
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977
STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)
K760662 · C.R. Bard, Inc. · Dec 1976
STERILIZER WRAP (CAT#221831,2,3,4,5,6)
K760661 · C.R. Bard, Inc. · Dec 1976